Solutions
Trypsin solutions
High-purity, animal-free trypsin solutions developed for reliable performance in regulated biopharmaceutical production.
TrypsiNNex®
TrypsiNNex® is an animal-free recombinant trypsin solution designed for consistent performance in regulated biopharmaceutical manufacturing. Based on recombinant porcine trypsin, TrypsiNNex® supports robust process control with a strong focus on safety, reproducibility, and regulatory readiness.
TrypsiNNex® is suitable for a wide range of biopharmaceutical applications, including cell dissociation, virus production, and protein processing and modification. By removing animal-derived raw materials, TrypsiNNex® helps reduce contamination risk and supports reliable, scalable and cost-effective manufacturing.
Advantages of TrypsiNNex®
TrypsiNNex® trypsin solutions are engineered to meet the demands of highly regulated biopharmaceutical production environments and offer clear advantages compared to animal-derived trypsin formulations.
Animal-free
Reduce viral contamination risk from raw materials with animal-free production.
High purity
Deliver consistent process performance with reliably high β-trypsin content.
High quality
Enable smooth qualification or transition with extensive documentation and support.
Available trypsin solutions
TrypsiNNex® is available in multiple sizes to support different process requirements:
Key specifications
- Enzymatic activity: >333,000 USP units/mL
- Product purity: ≥ 90% (α- and β-trypsin)
- β-trypsin content: ≥ 70%
- Protein content: 55–85 mg/mL
- Formulation: 10 mM HCl, 20 mM CaCl₂
Each solution is developed with the same focus on purity, consistency, and regulatory readi-ness. The lot-to-lot consistency is high, with a beta-trypsin content well above the specifica-tion.
Preparation of working or stock solution
TrypsiNNex® is supplied as a frozen, highly concentrated trypsin solution to be used for preparing working or stock dilutions matching specific operating conditions. This provides flexibility across different scales and applications while supporting consistent enzymatic per-formance. TrypsiNNex® is highly concentrated and does not contain EDTA, making it easily adaptable to different cell lines and conditions.
For thawing and dilution into working solutions, consult our User guide.
For regulated workflows, consistent handling is important to maintain activity and reproduc-ibility. When preparing working dilutions from a stock solution, use controlled conditions aligned with your process design to help ensure predictable results and reliable downstream performance.
Applications of TrypsiNNex®
TrypsiNNex® supports three primary applications:
Product list
Get a full overview and find the right solution that makes your process or product better.
Contact our Customer Support to place your order here.
Product information
TrypsiNNex® is GMP manufactured in accordance with IPEC’s guideline “The Joint Good Manufacturing Practices Guide for Pharmaceutical excipients” (2017) and applicable chapters in pharmacopoeias and ICH guidelines.
Enzymatic activity*: >333.000 USP units/ml
Product purity : ≥ 90 % (α- and β-trypsin)
β-trypsin content: ≥ 70%
Protein content: 55-85 mg/mL
Formulation: 10 mM HCl, 20 mM CaCl2
Bioburden (Microbial Count): ≤ 10 CFU/mL
Stability and storage: 36 months at –20ºC ±5ºC
*Alternative units
1 Chromozym TRY Unit: 21 USP Units
(Source: www.omicsonline.org)
- Certificate of analysis
- ISO 9001, 14001, 45001 certificates for Novo Nordisk Pharmatech’s management systems
- TrypsiNNex® user guide
- Quality statements: Origin/TSE, impurities, stability, primary packaging, manufacturing, etc.
- Regulatory Support File
- Supplier questionnaire
- SDS
- EcoVadis Sustainability report
- Novo Nordisk Pharmatech’s quality system meets DS/EN ISO 9001 and Novo Nordisk Pharmatech’s environmental systems meet DS/EN ISO 14001 and 45001.
- TrypsiNNex® is manufactured in accordance with GMP as defined by Novo Nordisk Pharmatech based on applicable chapters in DS/EN ISO 9001 and IPEC GMP guidelines for excipients (current version).
- TrypsiNNex® is produced by recombinant microbial expression in E.coli. No ingredients of animal origin are used in the cell banking and manufacturing process.
- TrypsiNNex® is antibiotic-free, both in production facilities and on a cell bank level.
- TrypsiNNex® is animal-free, meaning it is TSE compliant
Practical information
TrypsiNNex® is shipped on dry ice.
TrypsiNNex® should be stored at ‑20°C ±5ºC immediately upon arrival.
Please contact us for information on storage and handling after dilution.
If trypsin inhibitors are needed, we recommend using regular animal-free trypsin inhibitors, e.g. a Soybean Trypsin inhibitor.
In Biopharmaceutical production, detection of raw material is necessary:
- Incoming testing of TrypsiNNex® (e.g. identity, activity)
- Detection of residual raw material in the finished product (LOQ for HPLC-based purity measurement)
For support on incoming quality testing, please contact us.
Additional resources
More about TrypsiNNex®
TrypsiNNex® applications
TrypsiNNex® specifically addresses the need for a consistent, high-purity and high-quality enzyme in biopharmaceutical manufacturing.
